The impact of AZD4017 on bone turnover in post-menopausal osteopaenia
Research type
Research Study
Full title
Phase II Study Of The Impact Of AZD4017, A Selective 11b-HSD1 Inhibitor, On Biochemical Markers Of Bone Turnover In Post-Menopausal Osteopaenia
IRAS ID
126311
Contact name
Rachel Crowley
Contact email
Sponsor organisation
University of Leeds
Eudract number
2013-003387-32
ISRCTN Number
n/a
Research summary
Osteoporosis is a medical condition that leads to brittle bones that break (fracture) easily, assessed by a bone density scan (DXA). Osteoporosis is the disease which causes older people to break a hip when they fall, or to have fractures in the bones of their spine that cause pain and loss of height. These hip and spine fractures cause problems for millions of people around the world (9 million every year), with pain, hospital admissions, lack of independence at home or the need to move into sheltered/nursing home care, and even death from complications. Treating these problems costs the NHS over £2 billion per year.
There are some similarities between the bones of older people and the bones of people taking steroid medications. A new drug AZD4017 has been developed that reduces the level of steroids produced by the body itself, in local tissues; this may reverse some of the bone changes that are seen with ageing. This study is the first to look at the effect of this drug on bones.
One hundred post-menopausal women with osteopaenia (low-normal or slightly low bone density), will be randomised to receive either AZD4017 or placebo (dummy tablet with no drug in it) for 90 days. They will have 5 visits while taking the drug and another 3 months later, with blood tests and scans to check the effect of AZD4017 on bones, and urine tests to make sure that steroid production in the tissues is reduced in response to the drug. They will also have muscle tests (walk, stand and grip tests) to see if blocking steroid production has benefits for their muscle strength.REC name
South Central - Oxford B Research Ethics Committee
REC reference
13/SC/0523
Date of REC Opinion
11 Nov 2013
REC opinion
Further Information Favourable Opinion